Multiple SclerosisNCT05930379
A Feasibility Pilot Study on Lee Silverman Voice Treatment-Loud: a Telerehabilitation Approach
A study testing LSVT-Loud delivered by telerehabilitation and LSVT-Loud in the clinic in people with Multiple Sclerosis, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
Multiple Sclerosis (MS) is one of the most common causes of neurological disability in young adults. At least 62% of people with MS have speech, vocal, or communication disorders. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- LSVT-Loud delivered by telerehabilitation and LSVT-Loud in the clinic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jun 2023to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of MS according to the criteria of MC Donald 2010 (Polman et al., 2011; Thompson et al., 2018)
- perceived voice intensity disability and severity of speech and voice disorder prior to treatment (as judged independently by two speech-language pathologists highly experienced with voice and motor speech disorders)
- age ≥ 18;
- not treated for hypophonia in the six months before enrollment in the study
- with a preserved cognitive level at the Mini-Mental State Examination (MMSE test >24) (Folstein et al., 1975);
- available and able to use a PC with an internet connection at home to access the telerehabilitation sessions;
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- agreeing to participate with the signature of the informed consent form;
- stable drug treatment (last 3 months), if any;
- absence of relapses (last month) before taking part in the study.
Who cannot join
- presence of dysphonia related to other diseases;
- presence of other neurological disorders different from MS;
- presence of major psychiatric conditions;
- presence of severe impairment of visual and/or acoustic perception;
- history of laryngeal cancer, radiotherapy, or head-neck trauma, or intubation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Pilot Study on Lee Silverman Voice Treatment (LSVT)-Loud on Voice Intensity and Voice Use in Daily Living in People With Multiple Sclerosis: a Telerehabilitation Approach
Multiple Sclerosis (MS) is one of the most common causes of neurological disability in young adults. At least 62% of people with MS have speech, vocal, or communication disorders. Among these, alterations in voice intensity and quality constitute a limitation in MS people's social life leading to experience difficulties in work, conversations, and communication especially in noisy environments or through the telephone. Though voice and speech impairments and speech impairments are widely prevalent in this population, only 2% of the people receive speech therapy. The Lee Silverman Voice Treatment (LSVT)-Loud is a well-documented, efficacious intensive speech intervention, for treating hypophonia in subjects with neurological conditions. Despite the effectiveness of LSVT-Loud treatment on the voice has been reported in MS, several factors prevent the agile use of this method in rehabilitation centers: motor disability, work commitments, and distance barriers may preclude repeated attendance of this intervention at a healthcare facility. Telerehabilitation represents a feasible solution to bypass these potential barriers related to attendance at the rehabilitation programs in the clinic. The increasing evidence sustains the role of telerehabilitation for the migration of care from the clinic to the patient's homes, overcoming several obstacles affecting service accessibility. Previous studies showed the validity and the non-inferiority of LSVT-Loud delivered via telerehabilitation in subjects with Parkinson's Disease, while no pieces of evidence are still available on the efficacy of voice treatment delivered by telerehabilitation in MS. It is plausible to assume that LSVT-Loud delivered by telerehabilitation would be feasible and provide a beneficial effect also for MS non-inferior compared to the same treatment delivered in the clinic.
Read the detailed description
20 patients with MS will be recruited from IRCCS Fondazione Don Carlo Gnocchi ONLUS, Milan, according to inclusion/exclusion criteria detailed in the "Eligibility Criteria" section.
Participants will be randomized into 2 different groups:
Group 1: Lee Silverman Voice Treatment - Loud delivered by telerehabilitation at home (Experimental group); Group 2: Lee Silverman Voice Treatment - Loud delivered in the clinic (Control group).
- Conditions
- Multiple Sclerosis
- Being tested
- LSVT-Loud delivered by telerehabilitation, LSVT-Loud in the clinic
- Keywords
- Telerehabilitation, Speech Therapy, Multiple Sclerosis, Voice Intensity, Hypophonia, Digital Health
- Medical subject headings
- Multiple Sclerosis, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LSVT-Loud delivered by telerehabilitationOther
LSVT-Loud treatment delivered by telerehabilitation
LSVT-Loud in the clinicOther
LSVT-Loud delivered face-to-face in the clinic
| Study group | Role | What they receive |
|---|---|---|
| LSVT-Loud delivered by telerehabilitation | Experimental | F - Frequency: 7 times/week for 4 weeks according to a mixed model (4 days of synchronous sessions followed by independent practice + 3 asynchronous sessions); I - Intensity: sessions customized according to the patient's functional abilities to ensure the progression of difficulty in rehabilitation sessions; T- Time: each synchronous session will last about 60 minutes, each independent practice will last about 5-10 minutes, and each asynchronous session will last about 30 minutes; T- Type: Individual speech therapy sessions with the Lee Silverman Voice Treatment-Loud method delivered by telerehabilitation. Receives: Other: LSVT-Loud delivered by telerehabilitation |
| LSVT-Loud in the clinic | Active comparator | The frequency, intensity, time of the rehabilitation sessions will be the same as the experimental group.
T- Type: Individual speech therapy sessions with the Lee Silverman Voice Treatment-Loud method delivered in the clinic. Receives: Other: LSVT-Loud in the clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the vocal Intensity during 1-minute monologue dB SPL
Participants will be requested to speak about daily activities at a comfortable frequency and intensity level. A specific task identical for each participant will be given: "Please speak for at least a minute." For monologue (and other acoustic variables described below) recording setup follows published recommendations, mouth-to-microphone distance is kept at 30 cm and we will calculate the mean of the first three recordings and PRAAT software (www.praat.org) will be used to record and analyze voice parameters.
Measured: Baseline, post-treatment (up to 4 weeks)
Secondary outcomes (5)
Change in the vocal Intensity during 1-minute monologue dB SPL
Participants will be requested to speak about daily activities at a comfortable frequency and intensity level. A specific task identical for each participant will be given: "Please speak for at least a minute." For monologue (and other acoustic variables described below) recording setup follows published recommendations, mouth-to-microphone distance is kept at 30 cm and we will calculate the mean of the first three recordings and PRAAT software (www.praat.org) will be used to record and analyze voice parameters.
Measured: follow-up (up to 6 months from the end of the treatment)
Change in sustained /a/ voice intensity (dB SPL/a/)
Participants' voices will be monitored for a total of 4 hours of consecutive speech. Voice data from daily life will be registered using the Vocal Holter Med (VHM) before and after the interventions. VHM consists of a contact microphone placed in a collar worn around the neck as well as a device for data storage that can be worn in a pocket during the day. The contact microphone measures the skin vibrations caused by the activity of the vocal cords. Besides the voice indicators, also local temperature and relative humidity are measured during monitoring.
Measured: Baseline, post-treatment (up to 4 weeks) and follow-up (up to 6 months from the end of treatment)
Change in the perception of voice as measured by the Voice Handicap Index (VHI, Jacobson et al., 1997)
VHI is a standardized 30-point questionnaire, divided into three subscales covering functional, emotional, and physical aspects of voice disorders. Participants have to rate each statement using a 5-point scale scored from 0 (never) to 4 (always); the maximum score is 120 (worst score). The value of 12 points on the VHI test should be considered as a threshold for rating the handicap caused by voice disorders.
Measured: Baseline, post-treatment (up to 4 weeks) and follow-up (up to 6 months from the end of treatment
hange in perceived quality of life (especially in cognition, life activities, and participation domain) as measured by the World Health Organization disability assessment schedule 2.0 (WHODAS 2.0; Federici et al., 2017)
WHODAS 2.0 covers six domains of functioning including Cognition, Mobility, Self-care, Getting along, Life activities, Participation. Scores assigned to each item are on a 5-point scale ranging from (0) "none" to (4) "extreme" with higher scores indicating a higher disability. The 36-item version will be administered and both summary scores (score range 0-144 with higher numbers indicating higher disability) and domain-specific scores for the six different functioning domains (especially in cognition, life activities, and participation domain; score range 0-24 for each domain with higher numbers indicating higher disability) will be considered.
Measured: Baseline, post-treatment (up to 4 weeks) and follow-up (up to 6 months from the end of treatment
Protocol adherence
Synchronous sessions' adherence to the treatment will be registered by the telerehabilitation platform (experimental group) or by the therapist (control group). Asynchronous sessions' attendance will be registered by the completion of the patient's diary.
Measured: post-treatment (up to 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start10 Jun 2023
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Italiana Sclerosi Multipla
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930379
- Sponsor's protocol ID
- ON-LOUD
- Status last verified
- Dec 2024
- First submitted
- 26 Jun 2023
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Pilot Study on Lee Silverman Voice Treatment (LSVT)-Loud on Voice Intensity and Voice Use in Daily Living in People With Multiple Sclerosis: a Telerehabilitation Approach
- ClinicalTrials.gov ID
- NCT05930379
- Acronym / sponsor ID
- ON-LOUD
- Conditions
- Multiple Sclerosis
- Keywords
- Telerehabilitation, Speech Therapy, Multiple Sclerosis, Voice Intensity, Hypophonia, Digital Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Fondazione Italiana Sclerosi Multipla
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multiple Sclerosis (MS) is one of the most common causes of neurological disability in young adults. At least 62% of people with MS have speech, vocal, or communication disorders. Among these, alterations in voice intensity and quality constitute a limitation in MS people's social life leading to experience difficulties in work, conversations, and communication especially in noisy environments or through the telephone. Though voice and speech impairments and speech impairments are widely prevalent in this population, only 2% of the people receive speech therapy. The Lee Silverman Voice Treatment (LSVT)-Loud is a well-documented, efficacious intensive speech intervention, for treating hypophonia in subjects with neurological conditions. Despite the effectiveness of LSVT-Loud treatment on the voice has been reported in MS, several factors prevent the agile use of this method in rehabilitation centers: motor disability, work commitments, and distance barriers may preclude repeated attendance of this intervention at a healthcare facility. Telerehabilitation represents a feasible solution to bypass these potential barriers related to attendance at the rehabilitation programs in the clinic. The increasing evidence sustains the role of telerehabilitation for the migration of care from the clinic to the patient's homes, overcoming several obstacles affecting service accessibility. Previous studies showed the validity and the non-inferiority of LSVT-Loud delivered via telerehabilitation in subjects with Parkinson's Disease, while no pieces of evidence are still available on the efficacy of voice treatment delivered by telerehabilitation in MS. It is plausible to assume that LSVT-Loud delivered by telerehabilitation would be feasible and provide a beneficial effect also for MS non-inferior compared to the same treatment delivered in the clinic.
Detailed description
20 patients with MS will be recruited from IRCCS Fondazione Don Carlo Gnocchi ONLUS, Milan, according to inclusion/exclusion criteria detailed in the "Eligibility Criteria" section.
Participants will be randomized into 2 different groups:
Group 1: Lee Silverman Voice Treatment - Loud delivered by telerehabilitation at home (Experimental group); Group 2: Lee Silverman Voice Treatment - Loud delivered in the clinic (Control group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LSVT-Loud delivered by telerehabilitation | Experimental | Other: LSVT-Loud delivered by telerehabilitationF - Frequency: 7 times/week for 4 weeks according to a mixed model (4 days of synchronous sessions followed by independent practice + 3 asynchronous sessions); I - Intensity: sessions customized according to the patient's functional abilities to ensure the progression of difficulty in rehabilitation sessions; T- Time: each synchronous session will last about 60 minutes, each independent practice will last about 5-10 minutes, and each asynchronous session will last about 30 minutes; T- Type: Individual speech therapy sessions with the Lee Silverman Voice Treatment-Loud method delivered by telerehabilitation. |
| LSVT-Loud in the clinic | Active comparator | Other: LSVT-Loud in the clinicThe frequency, intensity, time of the rehabilitation sessions will be the same as the experimental group. T- Type: Individual speech therapy sessions with the Lee Silverman Voice Treatment-Loud method delivered in the clinic. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- diagnosis of MS according to the criteria of MC Donald 2010 (Polman et al., 2011; Thompson et al., 2018)
- perceived voice intensity disability and severity of speech and voice disorder prior to treatment (as judged independently by two speech-language pathologists highly experienced with voice and motor speech disorders)
- age ≥ 18;
- not treated for hypophonia in the six months before enrollment in the study
- with a preserved cognitive level at the Mini-Mental State Examination (MMSE test >24) (Folstein et al., 1975);
Key exclusion criteria (5 listed)
- presence of dysphonia related to other diseases;
- presence of other neurological disorders different from MS;
- presence of major psychiatric conditions;
- presence of severe impairment of visual and/or acoustic perception;
- history of laryngeal cancer, radiotherapy, or head-neck trauma, or intubation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LSVT-Loud delivered by telerehabilitationLSVT-Loud treatment delivered by telerehabilitation | Other | LSVT-Loud delivered by telerehabilitation |
| LSVT-Loud in the clinicLSVT-Loud delivered face-to-face in the clinic | Other | LSVT-Loud in the clinic |
Primary outcome
Change in the vocal Intensity during 1-minute monologue dB SPL
Time frame: Baseline, post-treatment (up to 4 weeks)
Participants will be requested to speak about daily activities at a comfortable frequency and intensity level. A specific task identical for each participant will be given: "Please speak for at least a minute." For monologue (and other acoustic variables described below) recording setup follows published recommendations, mouth-to-microphone distance is kept at 30 cm and we will calculate the mean of the first three recordings and PRAAT software (www.praat.org) will be used to record and analyze voice parameters.
5 secondary outcomes
Change in the vocal Intensity during 1-minute monologue dB SPL
Time frame: follow-up (up to 6 months from the end of the treatment)
Change in sustained /a/ voice intensity (dB SPL/a/)
Time frame: Baseline, post-treatment (up to 4 weeks) and follow-up (up to 6 months from the end of treatment)
Change in the perception of voice as measured by the Voice Handicap Index (VHI, Jacobson et al., 1997)
Time frame: Baseline, post-treatment (up to 4 weeks) and follow-up (up to 6 months from the end of treatment
hange in perceived quality of life (especially in cognition, life activities, and participation domain) as measured by the World Health Organization disability assessment schedule 2.0 (WHODAS 2.0; Federici et al., 2017)
Time frame: Baseline, post-treatment (up to 4 weeks) and follow-up (up to 6 months from the end of treatment
Protocol adherence
Time frame: post-treatment (up to 4 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LSVT-Loud delivered by telerehabilitation and LSVT-Loud in the clinic in people with Multiple Sclerosis, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the vocal Intensity during 1-minute monologue dB SPL (time frame: Baseline, post-treatment (up to 4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.